ESSURE
Report
- Report Number
- 2951250-2020-07884
- Event Type
- Injury
- Date Received
- May 19, 2020
- Report Date
- April 26, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED STRESS INCONTINENCE, VAGINAL HAEMORRHAGE, ANEMIA, DYSPAREUNIA, ENDOMETRIOSIS, MENSES IRREGULAR, KIDNEY INFECTION, MIGRAINE, ALLERGY (DEPO-PROVERA; IMPLANON; NUVARING), MULTIGRAVIDA, PARITY 4, OBESITY, MASTITIS, PELVIC BONE PAIN, SEXUAL ABUSE, TRAUMA, CYST OF OVARY AND ELECTIVE ABORTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DIFLUCAN, METRONIDAZOLE, NAPROSYN, TYLENOL, MIRENA IUD, GUMMY BEAR MULTIVITAMIN AND MACROBID. CONCURRENT CONDITIONS INCLUDED VAGINAL DISCHARGE, HOT FLASHES, SERUM FERRITIN DECREASED, LOW BACK PAIN, VAGINAL BLEEDING, VAGINAL ITCHING, VAGINAL DISCHARGE, VAGINITIS BACTERIAL, NAUSEA, TEMPERATURE ELEVATION, DECREASED APPETITE, CONSTIPATION, RECURRENT URINARY TRACT INFECTION, MICROSCOPIC HEMATURIA, PAINFUL PERIODS, ENDOMETRIAL POLYP, DYSMENORRHEA AND MENOMETRORRHAGIA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA"), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), METRORRHAGIA ("METRORRHAGIA"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"), VULVOVAGINAL CANDIDIASIS ("CANDIDAL VAGINOSIS"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHE") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATIONS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COILS). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, METRORRHAGIA, BACTERIAL VAGINOSIS, VULVOVAGINAL CANDIDIASIS, FATIGUE, MIGRAINE, HEADACHE AND WEIGHT INCREASED HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACTERIAL VAGINOSIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, METRORRHAGIA, MIGRAINE, PELVIC PAIN, POST PROCEDURAL COMPLICATION, PSYCHOLOGICAL TRAUMA, VULVOVAGINAL CANDIDIASIS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NO. OF TRAILING COILS ON EACH SIDE- RIGHT ¿ 01; LEFT- 05. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: IMPRESSION: BLOCKED BILATERAL FALLOPIAN TUBES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S SOCIAL MEDIA RECORDS: PELVIC PAIN, FATIGUE, INCREASED, LOT NUMBER: 955814, MANUFACTURE DATE: 2012-02, EXPIRATION DATE: 2015-02. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-APR-2021: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED STRESS INCONTINENCE, VAGINAL HAEMORRHAGE, ANEMIA, DYSPAREUNIA, ENDOMETRIOSIS, MENSES IRREGULAR, KIDNEY INFECTION, MIGRAINE, ALLERGY (DEPO-PROVERA; IMPLANON; NUVARING), MULTIGRAVIDA, PARITY 4, OBESITY, MASTITIS, PELVIC BONE PAIN, SEXUAL ABUSE, TRAUMA, CYST OF OVARY AND ELECTIVE ABORTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DIFLUCAN, METRONIDAZOLE, NAPROSYN, TYLENOL, MIRENA IUD, GUMMY BEAR MULTIVITAMIN AND MACROBID. CONCURRENT CONDITIONS INCLUDED VAGINAL DISCHARGE, HOT FLASHES, SERUM FERRITIN DECREASED, LOW BACK PAIN, VAGINAL BLEEDING, VAGINAL ITCHING, VAGINAL DISCHARGE, VAGINITIS BACTERIAL, NAUSEA, TEMPERATURE ELEVATION, DECREASED APPETITE, CONSTIPATION, RECURRENT URINARY TRACT INFECTION, MICROSCOPIC HEMATURIA, PAINFUL PERIODS, ENDOMETRIAL POLYP, DYSMENORRHEA AND MENOMETRORRHAGIA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA"), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), METRORRHAGIA ("METRORRHAGIA"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"), VULVOVAGINAL CANDIDIASIS ("CANDIDAL VAGINOSIS"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHE") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATIONS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COILS). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, METRORRHAGIA, BACTERIAL VAGINOSIS, VULVOVAGINAL CANDIDIASIS, FATIGUE, MIGRAINE, HEADACHE AND WEIGHT INCREASED HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACTERIAL VAGINOSIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, METRORRHAGIA, MIGRAINE, PELVIC PAIN, POST PROCEDURAL COMPLICATION, PSYCHOLOGICAL TRAUMA, VULVOVAGINAL CANDIDIASIS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NO. OF TRAILING COILS ON EACH SIDE- RIGHT ¿ 01; LEFT- 05. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON 20-AUG-2012: IMPRESSION: BLOCKED BILATERAL FALLOPIAN TUBES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S SOCIAL MEDIA RECORDS: PELVIC PAIN, FATIGUE, INCREASED, QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-APR-2021: MR RECEIVED. REPORTER INFORMATION, PATIENT'S RACE INFORMATION, MEDICAL HISTORY, LAB DATA, LOT NUMBER, AUTO NARRATIVE SUPPLEMENT AND RCC WERE ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA"), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), METRORRHAGIA ("METRORRHAGIA"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"), VULVOVAGINAL CANDIDIASIS ("CANDIDAL VAGINOSIS"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHE") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATIONS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COILS). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, METRORRHAGIA, BACTERIAL VAGINOSIS, VULVOVAGINAL CANDIDIASIS, FATIGUE, MIGRAINE, HEADACHE AND WEIGHT INCREASED HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACTERIAL VAGINOSIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, METRORRHAGIA, MIGRAINE, PELVIC PAIN, POST PROCEDURAL COMPLICATION, PSYCHOLOGICAL TRAUMA, VULVOVAGINAL CANDIDIASIS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-2020: PIF RECEIVED- PREVIOUSLY REPORTED EVENT INJURY WAS REPLACED WITH PELVIC PAIN. EVENT DYSPAREUNIA, MENORRHAGIA, FATIGUE, MIGRAINE, WEIGHT GAIN, HEADACHE WERE ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 532476 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 955814 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other| R |